MannKind Corp. shares were surging on the first full day of trading since the Food and Drug Administration approved the Valencia company’s inhaled insulin treatment for people with diabetes.
Late Friday, the FDA announced that it had approved MannKind’s Afrezza, a dose of good news after more than a decade of research, trials and setbacks. The powder insulin is inhaled through a handheld device, a quick puff replacing an injection.
MannKind shares were up 11% to $11.08 at noon Pacific time.
There is some debate about how wide demand will be for Afrezza. Pfizer had previously marketed the inhaled insulin product Exubera, but pulled it from the market in 2007 because of poor sales.
MannKind founder and chief, Alfred E. Mann, told the Los Angeles Times that Afrezza will succeed where Exubera failed because Afrezza acts much faster than insulin injections, providing an additional benefit to its convenience.
Adnan Butt, an analyst with RBC Capital Markets, said in a June 12 report that he sees huge potential demand for the drug.
"Afrezza would be the most convenient, discreet and rapid-acting insulin alternative for diabetes, one of the largest pharmaceuticals markets," Butt said.
He forecast that Afrezza could eventually reach $5 billion to $7 billion in annual sales. He estimated that the company's stock will be trading at $16 a share within a year.
The news from the FDA on Friday was not entirely positive. The agency will require MannKind to include a warning on the label that Afrezza should not be used by people with asthma or chronic obstructive pulmonary disease.